K870807 is an FDA 510(k) clearance for the BKS-1000 REFRACTIVE SET USE IN KERATOREFRACTIVE. This device is classified as a Keratome, Ac-powered (Class I - General Controls, product code HNO).
Submitted by Allergan, Inc. (Santa Ana, US). The FDA issued a Cleared decision on May 29, 1987, 91 days after receiving the submission on February 27, 1987.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4370.
| 510(k) Number | K870807 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 27, 1987 |
| Decision Date | May 29, 1987 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HNO — Keratome, Ac-powered |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.4370 |